DSCO - dieses Mal könnte es klappen... - 500 Beiträge pro Seite

[Gustl24]

nach jahrelangem unendlichen ringen um die zulassung
ihres lead-produktes SURFAXIN könnte es nächste woche ENDLICH mit der
zulassung in usa klappen - dies wäre der befreiungsschlag
für das gebeutelte biotech-unternehmen!

in der usa wird schon kräftig "getrommelt" und die aktie steigt
im vorfeld der entscheidung nächster woche relativ stetig...:

eine zitierte quelle in auszügen u.a.:

Buy Discovery Labs Before March 6 PDUFA Date

Seeking Alpha: Smith On Stocks February 22, 2012 | about: DSCO
The transformation of a biotechnology company from development stage to commercial can be the catalyst for a sustained increase in stock price. Discovery Laboratories (DSCO) received regulatory approval for its first product, Afectair, on February 2, 2012 and I believe that there is a strong possibility for approval of a second product Surfaxin on its PDUFA data of March 6, 2012. These are the catalysts for my new buy recommendation. DSCO also has built a highly promising pipeline based on Surfaxin LS (the next generation Surfaxin) and Aerosurf, which I consider one of the most promising product concepts in biotechnology.

daher aus aktuellem anlass dieser thread, da bestehende threads zu dieser
aktie bereits etwas "verwaist" sind...

grund hierfür ist sicherlich das endlose szenario der nicht-genehmigung
des produktes durch die FDA in der vergangenheit.

[Gustl24]

Antwort auf Beitrag Nr.: 42.823.068 von Gustl24 am 29.02.12 08:12:55

der äusserst kritische und berüchtigte adam feuerstein von
TheStreet...gibt dem produkt sogar eine gute zulassungs-chance...das will
etwas heissen...:

These Drugs Stocks Will Win FDA ApprovalBy Adam Feuerstein 02/16/12 - 12:04 PM EST
TheStreet's 2012 FDA Drug Approval Contest is in full swing, with 23 of the 59 contestants a perfect 4-0 so far.
More from Adam Feuerstein
The four drugs approved by FDA - from Amylin(AMLN), Vertex(VRTX), Roche-Curis(CRIS) and Teva(TEVA)-BioSante(BPAX) - have been relative layups. The challenging drug approval decisions lie ahead, starting tomorrow with Corcept Therapeutics(CORT) and its Korlym therapy for Cushing's Syndrome. This is where the contest should start to get interesting.
Forty-six percent of contestants are predicting an FDA rejection of Korlym versus 42% who are forecasting approval. The remaining 10% predict an FDA delay. Like I said, the Korlym approval decision is set for Friday.
Of the 23 contestants with perfect 4-0 records so far (I'm included in this illustrious group), 52% say Korlym gets rejected; 35% predict approval and 13% say no decision.
Here's how the approval predictions play out for the remaining drug approval decisions:
Columbia Labs(CBRX): Approval 5%; Rejection 88%; No decision 7%.

Discovery Labs(DSCO): Approval 47%; Rejection 49%; No decision 3%.

Astex Pharma(ASTX): Approval 36%; Rejection 46%; No decision 18%.

NeurogesX(NSGX): Approval 47%; Rejection 46%; No decision 7%.

MAP Pharma(MAPP): Approval 37%; Rejection 59%; No decision 3%.

Affymax(AFFY): Approval 68%; Rejection 22%; No decision 10%.

Chelsea Therapeutics(CHTP): Approval 53%; Rejection 43%; No decision 3%.

Vivus(VVUS) (Qnexa): Approval 49%; Rejection 39%; No decision 12%.

Amgen(AMGN): Approval 53%; Rejection 42%; No decision 5%.

Vivus (Avanafil): Approval 76%; Rejection 19%; No decision 5%.

Note: Cell Therapeutics(CTIC_) was removed from the contest given the withdrawal of the pixantrone filing.

[Gustl24]

Antwort auf Beitrag Nr.: 42.823.143 von Gustl24 am 29.02.12 08:26:55

die zulassungen der letzten wochen entsprachen dann doch sehr
der prognose des obigen artikels - siehe CHTP,VVUS etc., welche
ähnliche chancen wie DSCO hatten...

darüberhinaus wird kolportiert, dass die zusammenarbeit zwischen
DSCO und FDA in der jüngsten vergangenheit bzgl. dieser zulassung sehr
intensiv war und nun alle hindernisse aus dem weg geräumt sein sollten.

dies ist meines wissens der 4te oder 5te anlauf zur zulassung...
das sollte man wissen!!

daher nachwievor ein sehr spekulatives investment...

ich habe gestern in usa gekauft!

[Gustl24]

Antwort auf Beitrag Nr.: 42.823.207 von Gustl24 am 29.02.12 08:39:27

mal noch ein beitrag aus einem us-board eines long-investors:

The saga and frustration in trying to satisfy the FDA is a long and complex story. A good part of the blame for the delay can be attributed to DSCO moving too rapidly in its anxiousness to get the product approved. The FDA was also culpable in not giving clear indications of what it considered necessary to validate frBAT. Both sides stepped back after the last CRL and took a more measured approach and for the first time the FDA laid out in writing what it considered to be the essential steps needed.

DSCO has worked very carefully to meet the requirements presented in the written instructions from the FDA. In recent corporate presentations, DSCO has discussed the issues that the FDA needs to resolve and has shown the painstaking detail that the company has used to try to meet these requirements. The data that has been generated appears to be what the FDA is looking for and I think that there is a high probability that the FDA will consider the frBAT as having been validated and grant marketing approval to Surfaxin.

[dlehmann]

Antwort auf Beitrag Nr.: 42.823.207 von Gustl24 am 29.02.12 08:39:27

Mir werden keine Umsätze in den USA angezeigt. Kannst Du mir dazu etwas sagen? Vielen Dank

[Gustl24]

Antwort auf Beitrag Nr.: 42.824.210 von Gustl24 am 29.02.12 10:57:11

meine persönliche prognose: 70-80 % chance auf approval

den werten der zugelassenen produkte beimessend erachte ich einen
möglichen kursgewinn von 60%-120% nach approval vom heutigen kurs
ausgehend...dies ist eher konservativ geschätzt...
in usa spinnen sie mit kursen zwischen 11-25 dollar...way tooo much...

aber 6-8 dollar erachte ich als möglich, wenn...........APPROVAL

[Gustl24]

Antwort auf Beitrag Nr.: 42.824.272 von dlehmann am 29.02.12 11:03:46

die letzten 4 handelstage in usa über 2 mio./tag an der nasdaq -
das entspricht ca. dem 5 fachen des normalen tagesvolumens...

[zwitscherton]

Würd mal sagen - diesmal muß es klappen - sonst Zappeduster.

Nachdem sie bereits 4 oder 5 mal mit dem Approval für Surfaxin gescheitert sind.

[Gustl24]

Antwort auf Beitrag Nr.: 42.825.126 von zwitscherton am 29.02.12 12:41:47

hatte ich ja schon geschrieben - s.o.
scheint aber die amis noch verrückter zu machen

[zpo]

.

Spannend

.

[Gustl24]

March Madness, Biotech Style
By Brian Orelli, The Motley Fool
Posted 3:18PM 02/29/12

Biotech investors are going to get their own version of March Madness starting next week, when three companies are due to hear decisions about their drugs over the course of two days.

...

Finally?
Discovery Labs (NAS: DSCO) has had a long road to approval of Surfaxin, including four rejections (if I caught them all) since the original application in 2004, but it could be over on March 6 as the biotech goes for its fifth attempt at approval.

The company didn't give up, because most of the issues have related to manufacturing, something that's more easily correctable than a drug's efficacy.
Is the fifth time the charm for Discovery Labs? Who knows. It appears the company has fixed everything the FDA wanted since the last rejection in 2009, but I went out on a limb and suggested a likely approval after the second rejection -- and after the third. Unlike with clinical trial data, investors get little visibility into the manufacturing issues. I'll stick with a caveat-laden prediction of an approval and hope it's the last one I have to make on Surfaxin.


sagt eigentlich alles...dann hoffen wir mal mit

[brazzo007]

Auch sehr interessant!
Discovery Labs (DSCO) has developed Surfaxin (lucinactant) for the prevention of respiratory distress syndrome (RDS) in premature infants. Surfaxin has an expected PDUFA decision date of 06 MAR 2012. Here, we analyze the key issue for Surfaxin’s latest NDA: demonstrating bioequivalence of the phase III trial formulation and the currently manufactured product.

Most DSCO followers consider improving and validating the fetal rabbit biological activity test (FRBAT) to be the primary focus of DSCO’s regulatory efforts over the last two years. That’s true. Here, we reframe FRBAT as a bioequivalence issue with important implications for FDA approval requirements.

Why bioequivalence?
Let’s begin by examining an excerpt from a 2009 8-K describing DSCO’s meeting with the FDA following the previous CRL (emphasis our own):

During Surfaxin’s Phase 3 clinical trials, a leading academic neonatologist assessed the biological activity of the clinical batches by measuring respiratory compliance in a well-established pre-term lamb model of RDS. After completing Surfaxin’s Phase 3 clinical trials, in accordance with discussions with the FDA, Discovery Labs validated and implemented the BAT as a recurring quality control test to confirm biological activity for Surfaxin release and stability testing. Based on agreements reached in meetings with the FDA in 2006 and 2008, Discovery Labs conducted a series of preclinical experiments to establish comparability between Surfaxin drug product used in Phase 3 clinical trials and the Surfaxin drug product intended to be manufactured for commercial use. Accordingly, Discovery Labs initiated a series of side-by-side studies employing both the pre-term lamb model of RDS and the BAT and believes that the correlated results demonstrate comparability and support approval of Surfaxin.

At the recent June 2 meeting, Discovery Labs presented a compilation of previously-submitted data from the pre-term lamb model and BAT studies, together with a comprehensive statistical evaluation of such data, intended to establish to the satisfaction of the FDA comparability of clinical drug product to Surfaxin drug product to be manufactured for commercial use. The comprehensive statistical evaluation was a comparative regression analysis using an accepted FDA statistical method. Discovery Labs believes that the data and related statistical evaluation that it submitted to the FDA are highly supportive of the comparability of clinical drug product to commercial Surfaxin.

The FDA stated, for the first time, that the 2006 and 2008 agreement with Discovery Labs to establish comparability through these studies is unprecedented and the determination of whether Discovery Labs has adequately established comparability is solely within the FDA’s discretion. The FDA now insists, for the first time, that data generated from the pre-term lamb model and BAT studies must demonstrate, in a point-to-point analysis, the same relative changes in respiratory compliance between both models over time. Based on this newly-defined standard, the FDA indicated that to adequately establish comparability in this manner would be an extremely high hurdle and that, from the FDA’s perspective, the data analysis provided by Discovery Labs did not meet that standard.

The FDA suggested that the comparability studies in the pre-term lamb model and the BAT would not be necessary if the BAT had been implemented to assess Surfaxin drug product used in the Phase 3 clinical trials. Additionally, the FDA suggested that, to increase the likelihood of gaining Surfaxin approval and as an alternative to demonstrating comparability using the pre-term lamb model and BAT, Discovery Labs could consider conducting a limited clinical trial employing only the BAT as a path forward to Surfaxin approval.

Slide 17 of DSCO’s Feb 2012 corporate presentation lists the requirements for validation of FRBAT. We reiterate an important bullet point below:

Therefore DSCO needed to link pre-term lamb results of biological activity of Surfaxin used in Phase 3 trial with FRBAT results of biological activity of currently manufactured Surfaxin; this also links Surfaxin used in the phase 3 trial to currently manufactured Surfaxin.

When a company changes a drug’s formulation, FDA requires the company to demonstrate bioequivalence. DSCO changed Surfaxin’s formulation, so what DSCO is calling “comparability” is in fact bioequivalence.

Here’s the tricky part: well-defined bioequivalence guidance exists for orally available drugs based on established pharmcokinetic (PK) models. However, no formal guidance exists (JAMP) for demonstrating bioequivalence of inhaled drugs because blood concentration PK parameters are not informative of pharmacodynamics (PD) when the drug is delivered directly to the lung and the lung is the site-of-action. Instead, one way to demonstrate bioequivalence of an inhaled drug is to show consistency of efficacy outcomes in a clinical trial, which is why FDA suggested DSCO pursue a limited clinical trial.

A surfactant is similar to an inhaled drug because it is delivered directly to the lungs via lavage. However, DSCO cannot conduct a human clinical trial to demonstrate bioequivalence because:

Bioequivalence tests are typically conducted in healthy adult volunteers. It is not possible to lavage the lungs of healthy adults who are not surfactant deficient.
A bioequivalence trial would need to be conducted in premature infants. The company claims in its 01 FEB 2011 Surfaxin Update, starting at 29:30, that the FDA agrees with its position that it is unethical to conduct a clinical trial in premature babies for the sole purpose of demonstrating bioequivalence. It’s possible this is simply management spin since we don’t know exactly what FDA said in the back and forth discussion. But for the purposes of this post, let’s assume FDA indeed reversed its position regarding the previous suggestion of a clinical trial.
In summary, DSCO needs to demonstrate bioequivalence between the two Surfaxin formulations. Surfaxin’s PD characteristics are similar to inhaled drugs. No formal bioequivalence guidance exists for inhaled drugs and DSCO cannot conduct something similar to past inhaled bioequivalence clinical trials in humans due to safety and ethical considerations. Thus, DSCO’s bioequivalance situation is unprecedented for the FDA and DSCO is in uncharted regulatory waters. DSCO is attempting to convince FDA of bioequivalence and link the two formulations together by showing agreement between two validated animal models.

Why did DSCO receive the last CRL?
We believe FDA rejected DSCO’s previous “correlated results” in 2009 because statistical research has shown that the naive approach of showing point-to-point concordance based on a Pearson correlation coefficient is flawed. See Measurement in Medicine: The Analysis of Method Comparison Studies and Statistical methods for assessing agreement between two methods of clinical measurement for a detailed discussion of why Pearson correlation is not suitable for method comparison.

We guess DSCO’s “comparative regression analysis” was similar to Finney’s method (see here and here). As described in the JAMP paper above, Finney’s method has problems when the dose-response curve (or time-response curve in DSCO’s case) is relatively flat. FDA has trouble evaluating Finney’s method in such cases (see: corticosteroids), which is probably why FDA did not accept the regression analysis. Further, simply comparing the slopes of two lines as DSCO mentions in its Surfaxin update presentations is not rigorous enough to demonstrate concordance.

We therefore believe FDA is looking for the point-to-point analysis method proposed in the papers above: a Bland-Altman plot. The Bland-Altman plot has become the standard for testing assay agreement, which is exactly what DSCO is attempting to show between the rabbit and lamb assays.

Assay Variance as a Limiting Factor
Below we highlight a quote from the “Statistical methods…” paper that shows the extent of DSCO’s challenge:

Repeatability is relevant to the study of method comparison because the repeatabilities of two methods of measurement limit the amount of agreement which is possible. If one method has poor repeatability – i.e. there is considerable variation in repeated measurements on the same subject – the agreement between the two methods is bound to be poor too. When the old method is the more variable one, even a new method which is perfect will not agree with it. If both methods have poor repeatability, the problem is even worse.

It is not possible to repeatedly test a surfactant in a single pre-term animal, so we can’t assess the repeatability of each model directly. But we know from DSCO’s Surfaxin update conference call on 28 SEP 2011 (fast forward to 29:00) that whole-animal biological activity tests such as the pre-term rabbit and pre-term lamb are highly variable, with coefficients of variation of up to 0.7. DSCO’s statistical challenge is to show that two independent, high-variance animal models can agree.

How much variance does each animal model have?
DSCO claims they can’t show real data in their Surfaxin presentations because the data is proprietary. Fortunately for us, pre-term rabbit and lamb models have been used for a long time for similar surfactants. DSCO has also previously published lucinactant data in a pre-term lamb model.

For pre-term lambs, variance can be extracted from the figure below (from: Pulmonary Distribution of Lucinactant and Poractant Alfa and Their Peridosing Hemodynamic Effects in a Preterm Lamb Model of Respiratory Distress Syndrome). Note: this is direct Surfaxin data. The figure shows pre-term lamb response to Lucinactant (Surfaxin, black dots) as a percent change in compliance. The error bars are standard error of the mean (SEM = standard deviation / sqrt(n)). Reading from the graph, mean = 237.5, SEM = 62.5, n=6. The SD = 153.09, which means the coefficient of variation of the percent change in compliance for the lamb model is approximately 0.65.


For pre-term rabbits, variance can be extracted from the figure below (from: Treatment Responses to Surfactants Containing Natural Surfactant Proteins in Preterm Rabbits). Note: this is *not* Surfaxin data, but this data is illustrative of how rabbits respond to SP-B and Surfaxin is a synthetic peptide of SP-B. The figure shows how pre-term rabbits respond to SP-B in terms of compliance alone. We need to convert compliance to a percent change of compliance over control to make it comparable with the figure above. Reading from the graph: control mean = 0.355, SEM 0.011, n = 15. SP-B mean = 0.822, SEM = 0.044, n=16. Converting this to percent change, the mean percent change is SP-B/Control = 2.31, which is on par with the lamb data. Using standard deviation rules, we calculate the percent change SD = 0.57, which means the coefficient of variation for the rabbit model is 0.25. This figure seems reasonable since the group who conducted this study have published many papers using pre-term rabbit models and DSCO was able to reduce the FRBAT variability by 40%.


Bioequivalence in the Bland-Altman Plot
Here is our assumption regarding DSCO’s proposed experimental protocol:

Manufacture multiple lots of Surfaxin for each shelf-life time point
Administer each lot to a paired pre-term rabbit and pre-term lamb. Each pair gets Surfaxin from the same lot.
Measure the percent change in pulmonary compliance over baseline for the pre-term rabbit and lamb.
Generate a Bland-Altman plot from paired data to show that the rabbit and lamb have “the same relative changes in respiratory compliance between both models over time.”
Regarding orally inhaled bioequivalence, the JAMP article states, “conventional bioequivalence studies are found acceptable if the 90% CIs comparing the test drug and reference drug products fall within the acceptable range of 80-125%.” This range is extended to 67-150% for pharmacodynamic bioequivalence limits used for the approval of generic albuterol CFC MDIs in the 1990s. We will assume a more liberal 67-150% range for assessing the bioequivalence of the rabbit and lamb models.

Translating this range into a Bland-Altman context, the 90% confidence interval of the difference between the paired rabbit and lamb percent change in compliance needs to fall within 67-150% of the mean lamb percent change to demonstrate bioequivalance (0.33 of the mean on the downside, 0.5 of the mean on the upside). The SD of the difference between the rabbit and the lamb = 163. The z-score for the 90% confidence interval is 1.645. Since the rabbit and lamb seem have approximately the same mean, the difference has mean = 0 with a 90% confidence interval of (-268,268).

-268 is well below the lower end of the 67% limit of -0.33 * 237.5 = -78.375. Likewise, 268 is above the upper end of the 150% limit of .5 * 237.5 = 118.75. DSCO will be unable to satisfy the PD bioequivalence requirements previously specified for inhaled albuterol. Even bringing the lamb coefficient of variation down to rabbit levels of 0.25 will not satisfy the upper limit. DSCO would have to decrease the standard deviation of each assay by 55% from the levels mentioned above to meet the albuterol criteria on the more lenient upper end.

Note: our confidence interval analysis is not perfect and needs some correction because it is not asymmetric from a ratio perspective, which is why we are going with the lenient upper bound. Although this analysis is assumes a Bland-Altman comparison, we feel the high variability of the rabbit and lamb models precludes showing rigorous agreement with any method.

Conclusions
The high variance inherent in whole-animal biological activity test assays will prevent DSCO from meeting established inhaled albuterol bioequivalence standards when assay agreement is examined in a Bland-Altman plot. This is purely a statistical problem due to the nature of the assay – DSCO’s next option moving forward is to conduct a clinical trial using the new formulation and demonstrate consistency in the clinical outcome as the FDA originally requested.

We have no doubt Surfaxin works. We would approve it based on common sense because it appears to be effective and safe from the clinical trials. If DSCO had stuck with their phase III formulation, they probably would have been approved a long time ago. But because DSCO changed the formulation, they have to conduct an unprecedented bioequivalance trial for a surfactant delivered by lung lavage. DSCO entered uncharted regulatory territory, where they became stuck between a rock and a statistical hard place – a nightmare scenario for any company seeking drug approval.

[Gustl24]

von fdatracker, gell

den haben sie aber inzwischen etwas angeschossen
in us-boards, in welchen er selbst mitschreibt...,

und er gibt inzwischen zu aktuelle präsentationen nicht gekannt zu haben...

zitat von ihm dort...:

Re: fdatracker tells DSCO will get CRL with good analysis
2-Mar-12 12:47 am

Thanks for the press release link. I'd missed it.
"The FDA has also acknowledged that Discovery Labs had successfully demonstrated in the preterm lamb model the comparability of Surfaxin clinical drug product to the to-be-marketed Surfaxin drug product."

So it seems they have shown bioequivalence.

das scheint wohl die entscheidente frage zu sein...:

zitat eines anderen us-board-mitglieds...:

...DSCO tries to use fetal rabbits instead of pre-term lambs for BAT (Biological Activity Test) for commercial production purpose. However, pre-term lamb is validated procedure that most resembles human pre-term baby in respiratory distress syndrome (RDS) model. One reason I guess is the size. A lamb is much more similar to our body than a rabbit. We can not do test validation in our own babies, which is unethical, so we must use a animal model to see if the Surfaxin manufactured is active or not, and how well it will perform biologically...
Company used pre-term lambs as BAT to monitor the quality of each batch in clinical trials. What FDA wants is to make sure fetal rabbits could be used as as good as pre-term lambs in validating the batch quality, which is nothing to do with "changing formulation" or "bio-equivalence"!

[Gustl24]

Antwort auf Beitrag Nr.: 42.839.367 von Gustl24 am 02.03.12 11:06:35

dienstag/spät. mittwoch wissen wir mehr...der rest ist spekulation und die
ungewissheit jeder FDA-entscheidung...

und irgendwann muß es ja DSCO auch mal schaffen...sonst wird´s
wirklich reif für G.buch der rekorde...we will see...

[zpo]

Wann soll denn am 6.3.2012 die FDA-Entscheidung kommen,
und wann kommt dann die news über ja oder nein?
Dienstag intraday, after market oder erst Mittwoch pre-market?
Gustl24, du hast doch mit so was Erfahrung.

[Gustl24]

Dienstag intraday, after market oder erst Mittwoch pre-market?

ist alles drei möglich...ich tippe eher auf dienstag...

irgendwas zwischen 13.00 und 23.00 deutscher zeit...we will see...

[Netflirter]

so bin jetyt auch dabei, bin mal gespannt ob es was wird wenn nicht dann halt beim 7ten mal
ne im ernst langsam solten doch alle Fragen bez[glich FDA aus dem weg ger'umt sein

[Kursziel1000]

Bin heute auch mit kleinen position bei DSCO eingestiegen.
Hoffentlich lassen und die Türsteher endlich mal in die Disco

[Kursziel1000]

Ich rechne damit das DSCO am Montag vom Handel ausgesetzt werden wird und am Dienstag nächbörslich die Entscheidung über die Ticker kommen.
Also am Mittwoch dann ganz groß nach oben oder ganz groß nach unten!

[Kursziel1000]

DSCO charts
http://investorshub.advfn.com/boards/read_msg.aspx?message_i…

[gauner1]

guten morgen

bin auch auf lauer. wundert mich, dass kurz vor der zulassung der kurs fällt !!!!

[gauner1]

nachtrag

vielleicht wird die sache wieder verzögert,daher der kursrückgang

[Gustl24]

der kursrücksetzer beunruhigt mich nicht...

schau dir vivus - VVUS - an...kurs auch drei handelstage vor
FDA-entscheidung gefallen...und dann...die amis sind eben sehr skeptisch...
FDA weiss man ja nie...

[brazzo007]

Weiss jemand wann die Entscheidung der FDA bekannt gegeben wird,
finde keine Uhrzeit und sitze auf Kohlen!
Danke vorab, und toi, toi, toi
allen Mitleidenden

[zpo]

.

Ist doch eigentlich egal.

Die Kursfindung wird danach so fix sein,
dass man eh nicht reagieren kann.

.

[gauner1]

wieso steigt der kurs in usa trotz sehr negativn umfeld ?

[brazzo007]

3,83 $ Dollar. 52 Wochenhoch geknackt. Hoffe jetzt was!

[brazzo007]

4,10 $ Disco Time!

[gauner1]

12%

der zug ist gelaufen

[gauner1]

bis jetzt 23%

[Gustl24]

Antwort auf Beitrag Nr.: 42.860.016 von gauner1 am 06.03.12 19:03:27

trotz sehr negativn umfeld ?

wer sagt das?

ein bisschen was sickert immert durch - HOFFEN wir mal das dieser kurze
hüpfer seinen grund hatte

[zpo]

.

kurze Hüpfer ist gut, klasse Volumen

.

[gauner1]

Antwort auf Beitrag Nr.: 42.860.181 von Gustl24 am 06.03.12 19:24:22

weil alle indizes bei uns und in usa tief rot sind

[zpo]

.

has good news leaked out?

oder war das nur ein Auslösen diverser stop-buys,
die bei 3,80 ... 4,00 USD ... platziert waren ?

das wäre aber geschickt manipuliert gewesen, wenn jetzt
ein reject käme oder ein weiterer CRL oder wie das heißt

.

[zpo]

.

Um so geschickter, da ich 500 zu 4,14 genommen habe ...

.

[gauner1]

Antwort auf Beitrag Nr.: 42.860.309 von zpo am 06.03.12 19:42:06

genau so ist es gewesen, wie du schreibst. nur sb

[zpo]

.

aber was für ein Umsatz damit plötzlich los getreten wurde,
klasse.

.

[zpo]

.

Sensationell,

dann will jetzt aber für meine Doofheit auch königlich belohnt werden.

.

[zpo]

.



.

[RTLOLDY]

Antwort auf Beitrag Nr.: 42.860.570 von zpo am 06.03.12 20:25:05

Da scheinen die Bullen in eine Falle getapst zu sein ???!!!

[Netflirter]

Antwort auf Beitrag Nr.: 42.860.608 von RTLOLDY am 06.03.12 20:31:21

immerhin noch Plus nachdem alles fällt Das Risiko ist auch sehr hoch naja bald wissen wir bescheid

[RTLOLDY]

Antwort auf Beitrag Nr.: 42.860.640 von Netflirter am 06.03.12 20:35:12

Kleiner Tipp, diese Accounts in Twitter verfolgen.
Die halten einen auf dem Laufenden.

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---> Tony Pelz - @biotechtraderHB
Former Prop Trader. Author of “The Biotech Trader Handbook” (available on Amazon).
Co-Founder of ChimeraResearchGroup.com. Operator of PelzOptions.com

[zpo]

.

Die Entscheidung dürfte eh heute ah oder morgen pm
veröffentlicht werden, insofern ist es wohl ziemlich egal,
was die heute noch so mit dem Kurs zu treiben belieben.

Morgen 200 % plus oder 70 % minus (rd.ca.und.geschätzt)

.

[Netflirter]

Antwort auf Beitrag Nr.: 42.860.689 von RTLOLDY am 06.03.12 20:41:19

danke dir.
Gruß

[brazzo007]

DSCO vom Markt ausgesetzt. Jetzt gilts!

[Kursziel1000]

DSCO- Trading Halted on this security

[zpo]

.

jetzt gilts

seit ihr alle schon wieder raus ?

.

[Kursziel1000]

Discovery Labs $DSCO announces FDA approval for surfaxin(R)

[zpo]

.

Ja, meine Fresse, dann waren die 4,14 nicht so blöd,

puuuuuuuuuuuuuhhh

.

[RTLOLDY]

From FDA PR on SURFAXIN, and important to know: "Surfaxin is the fifth drug approved in the United States to treat RDS in premature infants"

[Kursziel1000]

http://finance.yahoo.com/news/discovery-labs-announces-fda-a…

[Kursziel1000]

$DSCO to Resume Trading at 4:40pm

[zpo]

.

Paaaaaaarddeeeeeyy

.

[zpo]

.

Die shorts versuchen ah noch ihr bestes,
um morgen nicht Haus und Hof zu verlieren

.

[zwitscherton]

Better Late Than Never

[Gustl24]

Antwort auf Beitrag Nr.: 42.861.457 von zwitscherton am 06.03.12 23:04:25

DSCO - diesmal hat es geklappt siehe threadtitel-

glückwunsch allen
investierten - ich höre schon das zähneklappern der shorts in usa

[Gustl24]

Antwort auf Beitrag Nr.: 42.861.534 von Gustl24 am 06.03.12 23:22:12

die AH kurse in usa sind nur ein kleiner "vorgeschmack" -
morgen gibt´s ein "zerfleddern" der shorts - dieser titel
ist massiv geshortet...we will see...

[zwitscherton]

Antwort auf Beitrag Nr.: 42.861.534 von Gustl24 am 06.03.12 23:22:12

Mögen sie gegrillt werden.

[Kursziel1000]

DSCO A/H High: $6.85 , A/H Low: $3.4768

[Gustl24]

Antwort auf Beitrag Nr.: 42.861.565 von Kursziel1000 am 06.03.12 23:29:31

auch AH geht das spiel der MM´s munter weiter - viel spass - morgen
wird´s eng - von high 6,85 nochmal gedrückt

[zpo]

.

Alter Falter, vielleicht kommt man ja morgen doch noch vergleichsweise günstig rein bzw. nach

Ich singe jedenfalls schon mal:

D - (I) - S - C - O

Zieht's euch rein:

http://www.youtube.com/watch?v=GSi4HE0OBcA

P-a-r-t-y (!!!)

.

[zpo]

.

she is D: - delightfull

she is I: - incredilble

she is S: - sensationell

she is C: - sweetest candy

she is O: - oooohooohoooooohhhoo !

.

[Netflirter]

haha wie geil das hohe Risiko hat sich gelohnt YESSSSS
Glückwunsch uns investierten.
Schaut euch Human Genome an wie hoch die gingen :P jetzt geht es darum wann verkaufen

[gauner1]

guten morgen

ist die zulassung da ? ich finde nicht

[gauner1]

könnte sein, dass in denletzten minuten die shorties hochkaufen mußten ?

[zpo]

.

approval ist DA !!!

.

[gauner1]

wo bitte

[gauner1]

ich meine, ich finde keine veröffentlichung

[Schlood]

http://us.rd.yahoo.com/finance/external/cbsm/SIG=11iiumket/*…

[Gustl24]

ich finde keine veröffentlichung

jetzt bist du ja schon lange genug dabei...welche quellen nutzt du...
Bildzeitung???
es gibt dutzende quellen hier für FDA approval - selbst bei google...

[gauner1]

Antwort auf Beitrag Nr.: 42.862.550 von Gustl24 am 07.03.12 09:11:11

ich meinte, hier bei uns in wo nicht gefunden. gesucht habe ich wegen stress bei der arbeit nicht.

danke

[Gustl24]

der kurs von $ 5xx ist ein witz...aber es sind soviel manipulative
faktoren hier im spiel...da kann man den kurs heute schlecht
in usa vorhersehen...die boards in usa quellen über vor bashern und
spinnern...insb. jetzt nach der news...

[Netflirter]

Antwort auf Beitrag Nr.: 42.863.152 von Gustl24 am 07.03.12 10:34:20

immer cool bleiben, bis jetzt ist kurstechnisch noch nix passiert. Das einzige was sicher ist, das die shorter ein größes problem haben. Da kann man jetzt bashen und schlecht reden soviel sie wollen heute gehts massiv nach oben.

[Gustl24]

Antwort auf Beitrag Nr.: 42.863.321 von Netflirter am 07.03.12 10:57:08

ich bin cool...
aber wenn man 10 min. im us-board liest hat man das gefühl
im intranet einer irrenanstalt zu sein...

viel spass am nachmittag

[Netflirter]

das glaub ich dir. Denke mal viele von dennen, die jetzt schlecht reden dachten halt das es läuft wie die letzten male. Wäre ich mir sicher gewesen hätte ich deutlich mehr gekauft das sich jetzt die ärgern bzw brennen ist verständlich.
Dir auch Viel Spaß und nicht zu früh verkaufen

[Geisterzock]

Antwort auf Beitrag Nr.: 42.863.152 von Gustl24 am 07.03.12 10:34:20

Na der Kurs von 5,xx Dollar sei ein Witz sagst Du???

Komisch denn deine Wortwahl läßt drauf schließen das Du locker zweistellige Kurse für fair halten würdest.

Wenn ich mir da dein Posting Nr. 6 anschaue sagtest Du das die AMIS völlig übertreiben mit Kursen von 11 Dollar bei Zulassung.

selber nennst Du Kursziele von 6 Dollar welches gerade mal 17% über den nachbörslich gehandeltem Schlußkurs lag.

Es sieht für mich so aus als ob Du gerne aussteigen würdest hier in D und versuchst den Kurs in D nen bischen zu pushen.

[Geisterzock]

Es sind laut Yahoo gerade einmal 1 Millionen Shares short.

Also hört auf mit solche einer dummen Pusherei.

Was glaubt IHr wieviel in den letzten Tagen gecovert haben bei dem steigenden Kurs?

Ich schätze es gibt kaum noch Shorties in dem Wert und hier wird man böse überrascht werden heute mittag.

[Geisterzock]

Zudem muss man als Anleger ab jetzt mit einer täglichen Meldung rechnen das DSCO mehr Aktien auf den Markt schmeißt was eine starke Verwässerung wäre.

Sie haben ja NULL Kohle und brauchen Geld.

In der Vergangenheit hat man dies immer durch Dilution geregelt und so wird es auch dieses mal sein.

[gauner1]

gefällt mir überhaupt nicht, da will man mit 100 stücke den kurs hochziehen und die leute bescheißen

[new_investor]

Form 8-K for DISCOVERY LABORATORIES INC /DE/

7-Mar-2012

Other Events, Financial Statements and Exhibits


Item 8.01. Other Events.

On March 6, 2012, Discovery Laboratories, Inc. (the "Company"), issued a press release announcing that on March 6, 2012 the U.S. Food and Drug Administration (FDA) granted marketing approval for the Company's lead KL4 surfactant drug product, SURFAXIN� (lucinactant) for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS. SURFAXIN is the first synthetic, peptide-containing surfactant approved for use in neonatal medicine and provides healthcare practitioners with an alternative to the animal-derived surfactants that today are the standard of care to manage RDS in premature infants. A copy of the press release is attached hereto as Exhibit 99.1 and the text of such release is incorporated by reference herein.

In connection with the above announcement, the Company also is disclosing that it is planning to implement an operating plan intended to result in the commercial introduction of SURFAXIN in the U.S. in late 2012. In that regard, it expects to develop its own focused, specialty respiratory critical care commercial and medical affairs organization specializing in neonatal indications, beginning with SURFAXIN and, if approved, its other KL4 surfactant products for RDS: SURFAXIN LS� and AEROSURF�. The Company's strategy will focus primarily on hospitals with Neonatal Intensive Care Units (NICUs) believed to represent a significant portion of the current surfactant market in the U.S. To execute this strategy, the Company expects to incur annual expenses of approximately $12 - $13 million for commercial and medical affairs capabilities. The Company believes that this strategy will provide it direct control over its U.S. sales and marketing activities and permit it to establish a strong medical affairs presence in NICUs nationwide. The Company expects to be able to leverage this presence and the experience it will gain from introducing SURFAXIN nationwide to provide for an effective and efficient introduction of SURFAXIN LS and AEROSURF, if approved.

The Company expects that its commercial and medical affairs organization will also support the planned commercial introduction of AFECTAIR� in the U.S. and other major markets throughout the world. AFECTAIR devices are a series of novel ventilator circuit / patient interface connectors that simplify the delivery of inhaled therapies (potentially including the Company's aerosolized KL4 surfactant) to critical-care patients requiring ventilatory support by introducing the inhaled therapy directly at the patient interface and minimizing the number of connections in the ventilator circuit. It is believed that AFECTAIR will be of interest to a number of hospitals that, in addition to those with NICUs, have adult intensive care units (ICUs), pediatric intensive care units (PICUs) and critical care centers where AFECTAIR could be used to benefit critical care patients. Accordingly, the Company plans to further support the launch of AFECTAIR in the U.S. and the European Union through arrangements with third-party distributors experienced in introducing respiratory medical devices into hospitals. The Company expects that its commercial and medical affairs organizations will work in a coordinated manner with third-party distributors to assure that all hospitals with critical care facilities are aware of, and have access to, the AFECTAIR devices.

The Company has recently registered its initial AFECTAIR device, which has been designed for use with jet nebulizers and other aerosol generators, in the U.S. as a Class I, exempt medical device. The Company is planning to implement a regulatory and manufacturing plan that, if successful, could position it to initiate the commercial introduction of the initial AFECTAIR device in the U.S. and the European Union in the fourth quarter of 2012, and a second AFECTAIR device, AFECTAIR� DUO, which is being designed for use with vibrating mesh nebulizers (VMN), metered dose inhalers (MDI) and other aerosol generators, in 2013.

Financial Update

With the regulatory approval for SURFAXIN and initiation of activities with respect to the commercial introduction of SURFAXIN in U.S., as well as the registration and potential commercial introduction of AFECTAIR in the U.S. and the European Union, the Company believes it is better positioned to raise the capital required to execute the commercial introduction of SURFAXIN and AFECTAIR and to support its operations. It also believes that it is better positioned to potentially identify and enter into strategic alliances and other similar transactions that could provide development and international commercial expertise, as well as financial resources (potentially in the form of upfront payments, milestone payments, commercialization royalties and a sharing of research and development expenses) to support development and introduction of its pipeline products, beginning with SURFAXIN LS and AEROSURF, in various markets around the world. Although the Company is actively engaged in discussions with potential strategic and/or financial partners, there can be no assurance that any financing transaction or strategic alliance will be successfully concluded or available on terms favorable or acceptable to the Company.

The Company's business strategy and key planning goals for the remainder of 2012 include, among other things: (i) the commercial introduction of SURFAXIN in the U.S., and of AFECTAIR in the U.S. and the European Union, (ii) securing a strategic alliance to support the development and, if approved, eventual commercial introduction of SURFAXIN LS and AEROSURF in the European Union and markets outside the U.S., (iii) advancement of the SURFAXIN LS and AEROSURF development programs to be in a position to initiate planned Phase 3 and Phase 2 clinical trials, respectively, after securing a potential strategic partner, and
(iv) procuring the capital believed to be necessary and desirable to support the Company's activities until such time as the net revenues from its approved products, from potential strategic alliance and other collaboration arrangements, and from other future sources, such as warrant exercises, are sufficient to offset cash flow requirements.

As of December 31, 2011, the Company had cash and cash equivalents of $10.2 million. At the present time, the Company believes that it has sufficient capital to fund its operations into the second quarter of 2012. To execute its business strategy, the Company will need to secure infusions of capital and believes that such capital may be obtained from a combination of some or all of the following sources:

? Exercise of outstanding warrants:

o In February 2011, the Company issued 15-month warrants to purchase five million shares of its common stock at an exercise price of $2.94 per share (15-month warrants) that expire on May 22, 2012. Through, March 5, 2012, holders of the 15-month warrants have exercised warrants to purchase 275,000 shares of common stock, resulting in gross proceeds to the Company of $809,970. If the market price of the common stock should be greater than $2.94 per share in the period prior to the May 2012 expiration date, and if holders of the 15-month warrants decide in their discretion to exercise additional warrants, the Company potentially could raise up to an additional $13.9 million in proceeds from the exercise of the 15-month warrants.

o Also in February 2011, the Company issued five-year warrants to purchase five million shares of its common stock at an exercise price of $3.20 per share (2011 five-year warrants). These warrants expire in February 2016. As of March 5, 2012, the exercise price of the 2011 five-year warrants was $3.20 per share. If the market price of the common stock were to exceed $3.20 at any time prior to the expiration of the five-year warrants in February 2016, and if the holders of the five-year warrants were to exercise the warrants in their discretion, the Company could realize up to $16.0 million in additional proceeds from the exercise of the five-year warrants. (The 2011 five-year warrants contain anti-dilutive provisions that adjust the exercise price if the Company issues any common stock, securities convertible into common stock, or other securities (subject to certain exceptions) at a value below the then-existing exercise price of the 2011 five-year warrants. If the Company should complete a financing or other similar transaction involving the issuance of securities at values less than the then-existing exercise price of the 2011 five-year warrants, the exercise price of the 2011 five-year warrants may be adjusted downward).

o There can be no assurance that the market price of the common stock will remain at levels that make exercise of outstanding warrants likely, that holders of outstanding warrants will choose to exercise any or all of their warrants prior to the warrant expiration date. If the holders of outstanding warrants do exercise their warrants, because the exercise price will most likely be below the then-current market value of the common stock, any such exercises will have a dilutive effect on stockholders' interests.

? Equity financings in the public capital markets, including but not limited to potential additional financings under our CEFF and ATM Programs:

o The Company has a Committed Equity Financing Facility (CEFF) with Kingsbridge Capital Ltd. (Kingsbridge) that could allow it, at its discretion, to raise capital (subject to certain conditions, including volume limitations) at a time and in amounts deemed suitable to support its business plans. Based on the closing market price of the common stock on March 5, 2012 ($3.58) and assuming that all shares available under the CEFF are issued, the potential availability under the CEFF is approximately $3.6 million.

o In December 2011, the Company entered into a Sales Agency Agreement with Lazard Capital Markets LLC (Lazard), pursuant to which Lazard, as exclusive agent, may, at the Company's sole discretion and at such times that the Company may choose, sell up to a maximum of $15 million of shares of common stock through an "at-the-market" program (ATM Program). The ATM Program has a term of two years, subject to earlier termination. The Company is not required to sell any shares under the ATM Program and may adjust or cancel any order to sell at any time, although it will continue to be responsible for all trade executions that may have occurred prior to the time of adjustment or cancellation. Based on the closing market price of the common stock on March 5, 2012 ($3.58), and assuming that the full amount available under the ATM Program ($15 million) is sold, the Company may issue up to approximately 4.2 million additional shares under the ATM Program.

o In addition to these programs, the Company plans from time to time to consider equity public offerings to secure additional capital and strengthen the Company's financial condition.

o There can be no assurance, however, that the CEFF will be available at any time, or, even if available, that the Company will utilize the CEFF prior to its expiration in June 2013; that the Company will issue any shares pursuant to the ATM Program, or that the entire amount provided under the ATM Program will be realized prior the expiration or earlier termination of the ATM Program; or that the Company will undertake any financings or similar transactions, on favorable terms or otherwise. Even if the Company is able to raise additional capital through additional financings, such financings may only be available on unattractive terms, or, if consummated at prices below then-current market value, which could result in dilution of stockholders' interests.

? Upfront and milestone payments and co-funding of development activities associated with potential strategic alliances or other similar transactions:

o The Company is engaged in discussions with potential strategic partners who could provide development and commercial expertise as well as financial resources (potentially in the form of upfront payments, milestone payments, commercialization royalties and a sharing of research and development expenses) to support the development of SURFAXIN LS and AEROSURF and, if approved, the introduction of these products in Europe and various markets outside the U.S.. There can be no assurance, however, that the Company will be successful in concluding any strategic alliance, collaboration or other financing transaction.

? Secured debt arrangements to fund working capital and/or investment in capital assets:

o In the future, the Company believes that debt could potentially be a component of its capital structure and financing plans. Future debt arrangements could take the form of capital equipment financing facilities, revolving working capital lines of credit, term loans and other similar transactions to satisfy the Company's working capital requirements.

The Company believes, if it is successful in implementing its strategic business plan, the anticipated net revenues from the sale of SURFAXIN and AFECTAIR, when combined with the other sources of anticipated revenue, including from potential strategic alliances and collaboration arrangements to support the SURFAXIN LS and AEROSURF development programs, potentially could be sufficient to support future operations without having to undertake further dilutive financings. In that event, the Company would nevertheless continue to consider financings and similar transactions that would strengthen its financial condition and potentially build stockholder value.

Although the Company currently believes that it will be successful in meeting its strategic planning goals within the time frame set forth above, there can be no assurance: that the Company will successfully raise the funds required to meet its near-term capital requirements, through financing or similar transactions, or otherwise; that the Company will successfully fund and build its own commercial organization to support the commercial introduction of . . .


Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

99.1 Press release dated March 6, 2012

Cautionary Note Regarding Forward-looking Statements:

To the extent that statements in this Current Report on Form 8-K are not strictly historical, including statements as to business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of our product development, our plans regarding the anticipated commercial introduction of SURFAXIN and AFECTAIR, the anticipated strategic alliance for the development and commercialization of SURFAXIN LS and AFECTAIR or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this Current Report are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Such risks and others are further described in the Company's filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.

[Schlood]

http://finance.yahoo.com/news/media-alert-discovery-labs-hol…

[Gustl24]

Antwort auf Beitrag Nr.: 42.863.809 von Geisterzock am 07.03.12 12:04:56

Na der Kurs von 5,xx Dollar sei ein Witz sagst Du???

Komisch denn deine Wortwahl läßt drauf schließen das Du locker zweistellige Kurse für fair halten würdest.

Wenn ich mir da dein Posting Nr. 6 anschaue sagtest Du das die AMIS völlig übertreiben mit Kursen von 11 Dollar bei Zulassung.

selber nennst Du Kursziele von 6 Dollar welches gerade mal 17% über den nachbörslich gehandeltem Schlußkurs lag.

Es sieht für mich so aus als ob Du gerne aussteigen würdest hier in D und versuchst den Kurs in D nen bischen zu pushen.

na da ist ja ein ganz schlauer...uiiih!
punkt 1: wenn schon zitieren dann komplett und richtig:...aber 6-8 dollar erachte ich als möglich...sagte ich vor tagen...
und da sehe ich schon einen gewissen unterschied zu kursen aftermarket
gestern zu 5,10 und 5,20$...
punkt 2: habe ich schon mehrfach geschrieben, dass ich diese aktien nur
in usa handele...also kein pushen bei diesen lächerlichen umsätzen in D
punkt 3: sehe ich kurse von 11 $ IMMER noch als übertrieben an...
punkt 4: kannst du jetzt wieder unter deinen stein kriechen und bei yahoo
weiter mitlesen...ich kenne ja jetzt deine meinung und dein WISSEN...

[Gustl24]

Antwort auf Beitrag Nr.: 42.863.854 von Geisterzock am 07.03.12 12:10:50

Ich schätze es gibt kaum noch Shorties in dem Wert

na einen haben wir ja jetzt hier....

[Netflirter]

entlarvt den grünen bekommst von mir
ok klar brauchen sie bald Geld ist aber nix was neu ist neu ist aber das sie es zur Vermarktung brauchen. Eventuel kommt ein Partner daher und nimmt ihnen des ab wie sie schon sagen. Aber jetzt lauschen wir mal einfach die tel konvi zu dann wissen wir auch schon ein wenig mehr

[Gustl24]

Antwort auf Beitrag Nr.: 42.865.245 von Netflirter am 07.03.12 15:23:41

bin mal raus zu $ 5,25 - 5,30 in teilen...in usa...
aber natürlich weiter auf der lauer

[Netflirter]

Antwort auf Beitrag Nr.: 42.865.344 von Gustl24 am 07.03.12 15:36:16

riskant aber GW schöner gewinn. Ich warte noch kann auch ne weile darauf verzichten

[Netflirter]

jetzt könntest schon 10% billiger rein bin noch ein noob it zulassungen bei der nächsten weiß ich bescheid

[Netflirter]

streßfreier finde ich es denoch zu halten habe lang genug getradet wenn man jeden cent mitfiebert hmm nee kein bock mehr

[Gustl24]

Antwort auf Beitrag Nr.: 42.865.485 von Netflirter am 07.03.12 15:58:24

kommt jetzt drauf an, wie sie weiter finanzieren...muss man
im conference call jetzt beachten...

[Netflirter]

Antwort auf Beitrag Nr.: 42.865.548 von Gustl24 am 07.03.12 16:10:05

wann geht die nach unserer zeit an?

[Gustl24]

Antwort auf Beitrag Nr.: 42.865.649 von Netflirter am 07.03.12 16:26:15

schlood hat oben den link eingestellt...

[RTLOLDY]

If you guys want to scan through the $DSCO price predictions by fellow Twitter users click on this hashtag: #DSCO

https://twitter.com/#!/search/%23DSCO

[zpo]

.

Dass es im Anschluss nach einem Approval wieder runter geht, hat man ja schon öfter beobachten können.
Enttäuschend finde ich hier aber den beginner-spike.
Approval seit Jahren nun durch und das Ding schafft es fast, noch im Minus zu schließen.

.

[gauner1]

der kurs enttäuschend

auch enttäuschend die umsätze bei uns

[RTLOLDY]

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021…

[Geisterzock]

Ich habs Euch doch heute morgen gesagt das Ihr als Anleger enttäuscht werdet.

DSCO muss das Medikament selbst vermarkten da sich kein Partner erbarmen wollte sich dem anzunehmen.Das sagt eigentlich schon vieles.

Nachdem alle großen Pharmas nichts mit der Vermarktung zu tun haben wollten muss man davon ausgehen das der Jahresumsatz geringer als 50 Millionen sein wird.

Leute die Kiste wird wieder Richtung 2 Dollar zurücklaufen.

Ach ja und an Gustl:

Schön das Du morgens schreibst das der Kurs ein Witz sei und er nachmittags in den USA stark steigen wird. Dann aber nachmittags aussteigst.

Na ja dann hinterfrage mal dein Einschätzungsvermögen was das Aufnehmen von NEWS und deren Bedeutung angeht.

[Gustl24]

Antwort auf Beitrag Nr.: 42.867.759 von Geisterzock am 07.03.12 22:56:49

ein letztes mal für dich:

du sagtest:

...es sieht für mich so aus als ob Du gerne aussteigen würdest hier in D und versuchst den Kurs in D nen bischen zu pushen...

ich habe immer geschrieben diese aktie in usa gekauft/verkauft zu haben -
also kein pushen...die umsätze in D viel zu gering...haltlose unterstellung von dir...

nun von dir folgende weitere lächerliche unterstellung:

...schön das Du morgens schreibst das der Kurs ein Witz sei und er nachmittags in den USA stark steigen wird. Dann aber nachmittags aussteigst...

wann habe ich gesagt - bitte nachweis - die aktie würde in usa steigen?
ich habe die premarket-kurse in usa verfolgt, und nach zurückkommen der aktie entschieden in usa zu handelsstart zu verkaufen...
und den kurs in usa kann ja wohl kein board hier beeinflussen...

ich finde den kurs in usa immer noch übertrieben gering und
dem zukünftigen potential der company nicht gerechtfertigt, aber ich werde mich nicht (!)"gegen den markt stellen" und meine gewinne aufs spiel setzen...
das anstehende financing spielt sicherlich kurzfristig eine rolle...

aber du kannst mir gern per BM die nächsten kursentwicklungen der biotech-aktien mit anstehenden FDA-entscheidungen vorhersagen...denn du bist ein ganz toller hecht...und dann kann ich mit deinen spitzenprognosen noch viel geld verdienen...

[gauner1]

solange wartet man auf die zulassung und dann sowas. wer hätte das gedacht ? totale enttäuschung

[Gustl24]

Antwort auf Beitrag Nr.: 42.873.111 von gauner1 am 08.03.12 19:18:03

in usa wird jede anstehende FDA-entscheidung zum roulettespiel...

gutes geld auch bzgl. des risikos ist nur zu verdienen, wenn man deutlich
VOR der entscheidung investiert ist - dies war auch in diesem thread
das ziel und der fall...ich bin mit 50% plus kauf/verkauf an der nasdaq raus -

mit jeder starken kursreduzierung selbst nach positivem FDA-entscheid -
siehe BPAX, DSCO undund...- wird der abverkauf am nächsten tag
zukünftig immer wahrscheinlicher...
im falle eines negativen FDA-entscheids wie diese woche bei NGSX kostet es die hälfte der belegschaft den job und der kurs endet im nirwana...

[gauner1]

Antwort auf Beitrag Nr.: 42.874.676 von Gustl24 am 09.03.12 06:07:24

guten morgen

du hast recht. gratuliere zu deinem erfolg. bin bei dsco einigermaßen pari raus

bei bpax haben wir auch pech. seit 2 wochen wird nur manipuliert. jede centsteigerung wird durch die shorties mächtig verhindert.



gruß

[zpo]

.

dsco nun endlich wieder Trendumkehr ?

.

[zpo]

.

erwartete KE heute news

.

[gauner1]

morgen

was ist passiert ? wieso so ein stürzt ?

mögliche ke ?

[zpo]

.

Wieso mögliche KE ?

45 Mio USD zu 2,80 das Stück im offering,
entsprechend die eröffnung heute exakt 2,80 wohl, was


.

[brazzo007]

Guter Artikel:

http://seekingalpha.com/article/443621-cash-infusions-provid…

[zwitscherton]

Antwort auf Beitrag Nr.: 42.928.837 von brazzo007 am 20.03.12 13:44:15

ja, die cash-infusion hat den Kurs ja erstmal wieder niedergeprügelt.

[zwitscherton]

Antwort auf Beitrag Nr.: 43.071.060 von zwitscherton am 22.04.12 00:22:24

DSCO scheint grad wiederentdeckt zu werden.

http://seekingalpha.com/article/830571-discovery-laboratorie…

##

[zwitscherton]

Antwort auf Beitrag Nr.: 43.544.198 von zwitscherton am 28.08.12 23:31:03

Wer hätte das gedacht. Produktionstart für Surfaxin um 1/2 Jahr verschoben.

Aktienkurs bricht ein ...

They never fail to disappoint.

Discovery Labs Provides Commercial Update for SURFAXIN® and AFECTAIR®
http://finance.yahoo.com/news/discovery-labs-provides-commer…
During a recent review of the results and processes related to the analytical testing and quality control of SURFAXIN drug product, Discovery Labs determined that one of its analytical chemistry methods used to assess its drug product's conformance to specifications requires improvement and that an update to product specifications will be necessary. Discovery Labs has proactively communicated its findings regarding this analytical method to the U.S. Food and Drug Administration (FDA), has initiated a plan to improve and validate its analytical method, and plans to submit updated product specifications to the FDA. Based on the anticipated time required to improve the method, submit updated specifications, and await confirmation from the FDA, Discovery Labs anticipates that, if its plan is successful, the availability of SURFAXIN drug product will be delayed until early in the second quarter of 2013.

##

[zwitscherton]

Antwort auf Beitrag Nr.: 43.747.951 von zwitscherton am 24.10.12 19:07:34

Cash burn continues ...



Discovery Labs Reports Third Quarter 2012 Financial Results
http://finance.yahoo.com/news/discovery-labs-reports-third-q…

##

[zwitscherton]

Antwort auf Beitrag Nr.: 43.803.223 von zwitscherton am 08.11.12 18:25:34

Discovery Labs Appoints John R. Leone to Board of Directors
http://finance.yahoo.com/news/discovery-labs-appoints-john-r…

##

[zwitscherton]

Antwort auf Beitrag Nr.: 43.825.690 von zwitscherton am 14.11.12 21:54:32

Discovery Labs to Present at 2012 Piper Jaffray Health Care Conference
http://finance.yahoo.com/news/discovery-labs-present-2012-pi…

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[zwitscherton]

New Pharmacoeconomic Analysis Shows Lower Rate of Reintubation Observed With SURFAXIN® Treatment May Reduce Hospital Costs Associated with Bronchopulmonary Dysplasia
http://finance.yahoo.com/news/pharmacoeconomic-analysis-show…

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[zwitscherton]

Antwort auf Beitrag Nr.: 43.895.491 von zwitscherton am 05.12.12 21:09:00

unsurprisingly ...

Discovery Labs plunges on new Surfaxin delay
http://finance.yahoo.com/news/discovery-labs-plunges-surfaxi…
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[zwitscherton]

Cash burn continues ...

:O##

[zwitscherton]

Antwort auf Beitrag Nr.: 44.610.341 von zwitscherton am 10.05.13 23:44:03

Discovery Labs Prices $14.25 Million Public Offering of Common Stock
http://finance.yahoo.com/news/discovery-labs-prices-14-25-12…

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[zwitscherton]

Antwort auf Beitrag Nr.: 44.610.343 von zwitscherton am 10.05.13 23:44:57

Aus meinem eMail-Fach

Sag nicht ich hätte Dich nicht gewarnt.
Eine Bio-Klitsche, die seit 5 bis 8 Jahren ihr Surfax-Dingsda approved haben aber sich die ganze Zeit mit der FDA
darüber rumgestritten hatten, welches Tiermodell Hamster - oder Rotkehlchen nun das angemessene wäre um
die erforderlichenTestreihen durchzuführen - dann nachdem der damalige CEO zurückgetreten wurde endlich eingesehen
hatte, daß die FDA immer recht hat - nun bereits nach vorläufiger Zulassung für die Vermarktung wiederum bereits
im zweiten Anlauf gescheitert ist die Auflagen der FDA zu erfüllen.
Es benötigte in Folge wiederum des Rücktritts des amtierenden CEO - dessen Ehefrau nebenbei in dubioser Tätigkeit für
das Unternehmen an die 1 Mio. USD eingestrichen hatte - sowie der weiteren Verwässerung um ca. 30 Mio. USD.
Wenn sie es im Q3 auch nicht schaffen, dann drohen langsam die Patente für das Surfax-Dingsda zu verfallen.
Aber ansonsten aber sehr vertrauenswürdig der Laden.

Jörg

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[zwitscherton]

Antwort auf Beitrag Nr.: 44.702.983 von zwitscherton am 23.05.13 19:35:41

Discovery Labs Responds to FDA Request for Clarification of Recently Submitted SURFAXIN® (lucinactant) Updated Product Specifications
http://finance.yahoo.com/news/discovery-labs-responds-fda-re…

...gähn ...

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[zwitscherton]

Antwort auf Beitrag Nr.: 43.895.491 von zwitscherton am 05.12.12 21:09:00

Discovery Labs Presents Final Assessment in a Series of Pharmacoeconomic Analyses that Explore Impact of Reintubation on Healthcare Costs
http://finance.yahoo.com/news/discovery-labs-presents-final-…

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[zwitscherton]

Discovery Labs to Present at Stifel Healthcare Conference 2013

http://finance.yahoo.com/news/discovery-labs-present-stifel-…

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[zwitscherton]

Unbelievable ! They did it !!!



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[zwitscherton]

Antwort auf Beitrag Nr.: 45.569.473 von zwitscherton am 04.10.13 16:17:26

Discovery Labs Announces FDA Approval of SURFAXIN® (lucinactant) Updated Product Specifications

http://finance.yahoo.com/news/discovery-labs-announces-fda-a…

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[zwitscherton]

Discovery Labs Announces Notice of Allowance for a U.S. Patent Supporting the AEROSURF® Development Program

http://finance.yahoo.com/news/discovery-labs-announces-notic…

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[zwitscherton]

Discovery Labs Prices $50 Million Public Offering of Common Stock
http://finance.yahoo.com/news/discovery-labs-prices-50-milli…

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[zwitscherton]

Discovery Labs Announces Completion of $50 Million Public Offering

http://www.nasdaq.com/press-release/discovery-labs-announces…

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[zwitscherton]

Antwort auf Beitrag Nr.: 45.793.196 von zwitscherton am 08.11.13 15:27:26

Discovery Labs Announces U.S. Commercial Launch of SURFAXIN® (lucinactant)

http://www.nasdaq.com/press-release/discovery-labs-announces…

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[zwitscherton]

Antwort auf Beitrag Nr.: 45.793.226 von zwitscherton am 08.11.13 15:29:37

Discovery Labs to Host Conference Call to Discuss Third Quarter 2013 Results on Wednesday, November 13, 2013

http://www.nasdaq.com/press-release/discovery-labs-to-host-c…

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[zwitscherton]

Analyst sees future growth in Discovery Labs stock

http://finance.yahoo.com/news/analyst-sees-future-growth-dis…

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[zwitscherton]

Discovery Laboratories: Removal Of Financing Overhang A Catalyst For The Stock

http://seekingalpha.com/article/1833282-discovery-laboratori…

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[zwitscherton]

Discovery Labs Receives FDA Clearance of IND to Initiate AEROSURF® Phase 2 Clinical Program

http://finance.yahoo.com/news/discovery-labs-receives-fda-cl…

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[zwitscherton]

Antwort auf Beitrag Nr.: 45.826.018 von zwitscherton am 13.11.13 17:32:45

Discovery Labs Reports Third Quarter 2013 Financial Results

http://finance.yahoo.com/news/discovery-labs-reports-third-q…

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[zwitscherton]

DISCOVERY LABORATORIES INC /DE/ Financials

http://finance.yahoo.com/q/is?s=dsco

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[zwitscherton]

Discovery Labs to Present at the 25th Annual Piper Jaffray Health Care Conference

http://finance.yahoo.com/news/discovery-labs-present-25th-an…

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[zwitscherton]

Die kriegen aber auch gar nichts auf die Reihe ...
Why Discovery Laboratories Inc. Shares Tumbled

http://www.fool.com/investing/general/2014/03/13/why-discove…

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[zwitscherton]

Discovery Labs to Report 2014 First Quarter Financial Results and Hold Conference Call on Thursday, May 8, 2014

http://www.nasdaq.com/press-release/discovery-labs-to-report…

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[zwitscherton]

Discovery Labs Reports First Quarter 2014 Financial Results

http://www.nasdaq.com/press-release/discovery-labs-reports-f…

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[zwitscherton]

Discovery Labs Reports Second Quarter 2014 Financial Results

https://finance.yahoo.com/news/discovery-labs-reports-second…

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[zwitscherton]

Schon ein paar Tage alt ...
Discovery Labs Receives SBIR Grant Valued up to $3.0 Million to Support Development of Aerosolized KL4 Surfactant to Address Radiation-Induced Lung Injury

https://finance.yahoo.com/news/discovery-labs-receives-sbir-…

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[zwitscherton]

Discovery Laboratories: Collaboration With Battelle Is Validation Of Aerosurf's Potential By A Sophisticated Third Party

http://seekingalpha.com/article/2569815-discovery-laboratori…

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[zwitscherton]

Discovery Laboratories posts 3Q loss

http://finance.yahoo.com/news/discovery-laboratories-posts-3…

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[zwitscherton]

Discovery Labs to Hold Conference Call on Tuesday March 17, 2015 to Discuss Fourth Quarter 2014 Financial Results and Other Business Updates

http://www.nasdaq.com/press-release/discovery-labs-to-hold-c…

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[zwitscherton]

Antwort auf Beitrag Nr.: 49.326.866 von zwitscherton am 13.03.15 22:38:59

Nicht daß es irgendjemand interessieren würde.
Ursache dieses ful­mi­nanten Absturzes war...
Discovery Labs Reports Fourth Quarter 2014 Financial Results and Provides Update on SURFAXIN® (lucinactant) Intratracheal Suspension and AEROSURF® Program

https://finance.yahoo.com/news/discovery-labs-reports-fourth…

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[Gustl24]

Gestern wieder ein Lebenszeichen...
Einer der Kursgewinner in USA und nachbörslich ging's nochmals kräftig up bis an die 1,40$...
Heute Daten zur aktuellen Studie...wird spannend

[Gustl24]

Antwort auf Beitrag Nr.: 49.776.273 von Gustl24 am 14.05.15 06:43:19

...na könnt was werden...
bin gestern in USA zu 1,15$ gegen Ende rein...ride the waves!

Meldung vor paar Minuten aus USA:

WARRINGTON, Pa., May 14, 2015 /PRNewswire/ -- Discovery Laboratories, Inc. (DSCO), a specialty biotechnology company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases, today reported top line data from its recently completed AEROSURF® phase 2a clinical trial in premature infants with respiratory distress syndrome (RDS). Key objectives of the study were achieved, including (1) the primary objective of demonstrating the safety and tolerability of a single exposure of aerosolized KL4 surfactant administered in three escalating inhaled doses to premature infants 29 to 34 week gestational age and receiving nasal continuous positive airway pressure (nCPAP) for RDS, compared to infants receiving nCPAP alone, and (2) establishing proof of concept for the Company's proprietary technology platform based on physiological data suggesting that aerosolized KL4 surfactant is being delivered into the lung of premature infants, and acceptable performance of the novel capillary aerosol generator (CAG) technology in the neonatal intensive care unit (NICU).

"The ability to administer surfactant without invasive endotracheal intubation in the management of premature infants with RDS would represent a significant medical advancement. We are encouraged by the results from this AEROSURF phase 2a clinical trial as it represents a positive indication that our technology has the potential to achieve this goal. While the trial was designed as a safety study and the number of patients was limited, the results suggest that the Company's combination drug/device product has the ability to deliver aerosolized KL4 surfactant to the lungs of premature infants with RDS," commented Steve Simonson, M.D., Discovery Labs' Chief Development Officer. "These results will inform and improve the further development of our AEROSURF clinical program."
.....

[Gustl24]

Antwort auf Beitrag Nr.: 49.778.514 von Gustl24 am 14.05.15 13:25:47

Zum Börsenstart in USA mit knappen Plus noch raus...im premarket bereits deutlich zurückgekommen...
Diese Aktie ist nur für kurze Trades...ansonsten viel zu volatil und massiv geshortet...

Diese kurze Ausflug reicht mir wieder!